|
||||||||||||||||||
| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
 |
|
 |
 |
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
 |
|
California
In 2002, California followed Washington to become the second state to allow pharmacists to provide Emergency Contraception (EC) to the larger community under protocol with a physician. California used a legislative process, SB 1169, to make this change in the Pharmacy Practice Act in 2001. Prior to 2002, California had a restriction on collaborative protocols common to many states — what is sometimes referred to as the “one pharmacist, one physician, one patient” rule. California’s law further specified that the physician must first see the patient for the condition treated by the pharmacist. These restrictions prevented pharmacists from providing EC services direct to the community. However, these same restrictions did not technically prevent pharmacists from serving the patients of an authorizing health care facility. An independent community pharmacist in San Luis Obispo, who had earlier worked in Public Health and had been a member of the California Board of Pharmacy, began providing EC services to the clients of a local family planning clinic under a collaborative protocol with the medical director. This pharmacist had previously attended a training in Washington sponsored by PATH, and decided to replicate the practice on a limited basis in his own community. EC Pharmacy Demonstration ProjectIn 2000, the Pharmacy Access Partnership, a center of the non-profit Public Health Institute, formed a series of local demonstration projects using the San Luis Obispo model. The medical director for each clinic was designated as the authorizing prescriber. All participating facilities were family planning clinics, serving women for a pregnancy (fertility) related condition. This broad condition — fertility — then became the legal basis for pharmacists to initiate EC for women enrolled in the authorizing clinics. The Partnership developed a standardized protocol and service documents including an encounter form, consent sheet, and consumer cards alerting women to the fact they could go to a local pharmacy for EC. This “program structure” helped with recruitment efforts, particularly with pharmacists. With the help of both pharmacist and physician consultants, the Partnership actively recruited project participants. With the exception of San Luis Obispo, none of the pharmacists independently set up protocols with prescribers on their own prior to the 2002 law change. Demonstration sites were originally limited to a few communities in only seven counties. All participating providers served a high volume of family planning clients. The first participants included two local health departments, Planned Parenthood, a University student health center and a small teen clinic. Outreach required a dedicated hotline and website, even with the relatively small number of startup sites. Women needed an up to date resource outside identifying EC pharmacy locations. (Because new pharmacies joined the local EC network on a fairly regular basis, printed material identifying pharmacy locations were quickly outdated.) Outreach materials, with the hotline and website, were distributed to clients in participating clinic sites. Initially, only independent pharmacies agreed to participate. Similar to the pharmacist in San Luis Obispo, these early participants tended to be public-spirited and community oriented, and willing to push ahead for an important cause. Several early participants were also highly respected, key influencers in California’s pharmacy community and this helped significantly in recruiting new pharmacists. After six months into the demonstration project, the first chain pharmacies came on board – Longs, followed by Walgreens. Live trainings, performed by pharmacists, were held for prospective participants. The initial trainings were 20 hours – 12 hours of live program and eight hours of home study! Within several months this was shortened to six hours and then eventually four hours. The School of Pharmacy, University of Southern California and the California Pharmacist Association delivered these training programs. What Purpose did the EC Demonstration Project Serve?Simply put, the project created the political will to change pharmacy practice law in California allowing pharmacists to provide EC to the broader community. The demonstration project itself only minimally increased access to EC in California. Less than 1,000 women were served through these sites. The real value of the project was in showing pharmacists, physicians and lawmakers that it could be done! It helped calm anxieties that California might be different from Washington, the only other state at the time that allowed direct pharmacy access to EC. The demonstration sites also generated positive and valuable media attention, particularly after legislation was introduced. LegislationWork on state legislation (SB1169) was initiated in April 2001, approximately nine months after the demonstration project began. By that time almost 70 pharmacies were participating in the project. The bill inserted new and brief enabling language into the part of Pharmacy Practice Act that describes authorized pharmacist activities. The Public Health Institute (PHI) sponsored the bill, and Dede Alpert (D-San Diego), a senator with a strong track record in women and children’s issues, served as author. Strategically, PHI’s sponsorship was important. It helped diffuse scope of practice turf issues and minimized debate over abortion. A consultant familiar with pharmacy issues helped coordinate this legislation. This contrasts with Hawaii — the only other state to achieve EC pharmacy access through recent legislation — where experts in family and women’s issues helped coordinate legislation on a volunteer basis. Shortly after introduction, ACOG and Planned Parenthood came on board as supporters, and by the first floor vote a broad coalition of SB1169 supporters (DOC-28K) had formed. The California Pharmacy Association participated in crafting the bill, but did not come on as a formal supporter until after several prominent medical groups had registered their support. The bill passed both the Assembly and Senate, largely along party lines in California’s Democratically controlled legislature. The Governor signed the bill in October 2001 at a special bill signing ceremony, and SB1169 became effective January 2002. There is considerable variation in the types of requirements placed on EC protocol arrangements (see Summary of EC Models). California’s model is probably more decentralized than systems in Washington, Alaska and Hawaii. Board approval is not required and there is no central registration process. SB1169 had very general training requirements. It did not reference CE or that the program must be accredited. It simply stated: “a pharmacist shall have completed a training program on emergency contraception, which includes, but is not limited to, conduct of sensitive communications, quality assurance, referral to additional services and documentation”. However, it did have one limitation compared to Washington State. In California, an authorized protocol only covers the named pharmacist(s) on the protocol. In Washington, a prescriber signed protocol covers the named pharmacist(s) and all other pharmacists working in the store. SB1169 mandated that each woman who receives EC directly from a pharmacist receive a standardized fact sheet (PDF 260-K) that includes but is not limited to the “indications” for use of the drug, the appropriate method for using the drug, the need for medical follow up, and other appropriate information. The bill specified that “the board shall develop this form in consultation with the State Department of Health Services, the American College of Obstetricians and Gynecologists, the California Pharmacist Association and other health care organizations.” Implementation After LegislationImplementing the new EC pharmacy law in California was easier than it might have been as a result of the demonstration projects. The new program had a structure to build upon: there was a pharmacist training program for EC; the service component had already been adapted into several chains and a number of independent pharmacies; prototypes of collaborative practice agreements and basic service documents had already been developed. In spite of this support, it still required an enormous effort to make the transition. The Pharmacy Access Partnership began a statewide registry of EC pharmacies advertised through a new website (www.EC-Help.org) and state hotline that informs of EC pharmacy locations throughout the state. For the first six months of 2002, the vision for implementation was based on the concept of local physicians signing protocols. The Pharmacy Access Partnership, the main organization leading implementation, expected protocols with pharmacists to be authorized by community physicians, and that statewide EC pharmacy coverage would flow from these local partnerships. Towards that end, a page on the Partnership’s website was developed for physicians and explains the new law and the benefits from working with local pharmacists. A special brochure for physicians was created, and ACOG District IX sent out a mass mailing to approximately 3,000 physicians alerting them to the new law, and soliciting their participation in signing protocols with local pharmacists. However, by the middle of 2002 it was clear from a programmatic perspective that relying on locally arranged protocols was not going to make significant inroads into California’s very large retail pharmacy community. (This state has approximately 4,000 — 5,000 retail pharmacies.) Several factors probably held back local protocols: (1) physician perceptions about liability, (2) the often impersonal relationship between physicians and pharmacists in many California communities, and (3) lack of time on the part of either physicians or pharmacists to develop new relationships for an issue with little economic incentive. With the support of an OB/GYN with the University of California San Francisco, and medical directors of local Planned Parenthood affiliates, California began offering physician-signed protocols to all pharmacists completing recognized EC training programs. This turnkey approach where pharmacists could do everything at once — receive training, obtain access to a protocol, and register to advertise services — greatly accelerated the rate of pharmacist participation. Within a year, there were more than 700 retail pharmacies offering EC direct to the general public in California.
|